scholarly journals Safety and Efficacy of Direct Oral Anticoagulants for Atrial Fibrillation in Patients with Renal Impairment

Pharmacy ◽  
2020 ◽  
Vol 8 (1) ◽  
pp. 30 ◽  
Author(s):  
Soo Min Jang ◽  
Khaled Bahjri ◽  
Huyentran Tran

Direct oral anticoagulants (DOACs) are gaining popularity for patients with nonvalvular atrial fibrillation (AF) for stroke prevention. Less bleeding risk with comparable stroke prevention compared to warfarin was shown. DOACs have predictable anticoagulant effects, infrequent monitoring requirements and less drug-food interactions compared to warfarin. However, safety and efficacy data of DOACs in patients with chronic kidney disease (CKD) are limited. This is a retrospective study to evaluate thromboembolic and bleeding events in patients with AF (with/without CKD) in October 2010 and July 2017. A total of 495 patients were included and only 150 patients had CKD. Our study found that patients with renal impairment on a DOAC do not have a higher incidence of bleeding events. It showed significant increase in thromboembolic events in CKD patients with dabigatran compared to CKD patients with apixaban with odds ratio of 6.58 (95%CI 1.35–32.02, p = 0.02).

2021 ◽  
Vol 27 ◽  
pp. 107602962098790
Author(s):  
Clara Ting ◽  
Megan Rhoten ◽  
Jillian Dempsey ◽  
Hunter Nichols ◽  
John Fanikos ◽  
...  

Patients with renal impairment require dose adjustments for direct oral anticoagulants (DOACs), though there is uncertainty regarding their use in severe chronic kidney disease. Inappropriately dosed DOACs may increase risk of ischemic events when under-dosed, or risk of bleeding when over-dosed. The purpose of this study was to describe DOAC selection, dosing strategies, and associated clinical outcomes in patients with moderate to severe renal impairment at our institution. This was a single-center retrospective analysis of adult outpatients with moderate to severe renal impairment (estimated creatinine clearance <50 mL/min, including need for hemodialysis) who were prescribed a DOAC by a cardiologist between June 1, 2015 and December 1, 2018. Outcomes evaluated included the percentage of patients who received appropriate and inappropriate DOAC dosing, prescriber reasons for inappropriate DOAC dosing if documented, and incidence of thrombotic and bleeding events. A total of 207 patients were included. Overall, 61 (29.5%) patients received inappropriate dosing, with 43 (70.5%) being under-dosed and 18 (29.5%) being over-dosed as compared to FDA-labeled dosing recommendations for atrial fibrillation or venous thromboembolism (VTE). By a median follow-up duration of 20 months, stroke occurred in 6 (3.3%) patients receiving DOACs for atrial fibrillation, and VTE occurred in 1 (4.3%) patient receiving a DOAC for VTE. International Society on Thrombosis and Haemostasis major or clinically relevant nonmajor bleeding occurred in 25 (12.1%) patients. Direct oral anticoagulants were frequently prescribed at off-label doses in patients with moderate to severe renal impairment, with a tendency toward under-dosing.


2020 ◽  
Vol 29 (02) ◽  
pp. 088-097
Author(s):  
Anwar Santoso ◽  
Sunu B. Raharjo

AbstractAtrial fibrillation (AF), the most prevalent arrhythmic disease, tends to foster thrombus formation due to hemodynamic disturbances, leading to severe disabling and even fatal thromboembolic diseases. Meanwhile, patients with AF may also present with acute coronary syndrome (ACS) and coronary artery disease (CAD) requiring stenting, which creates a clinical dilemma considering that majority of such patients will likely receive oral anticoagulants (OACs) for stroke prevention and require additional double antiplatelet treatment (DAPT) to reduce recurrent cardiac events and in-stent thrombosis. In such cases, the gentle balance between bleeding risk and atherothromboembolic events needs to be carefully considered. Studies have shown that congestive heart failure, hypertension, age ≥ 75 years (doubled), diabetes mellitus, and previous stroke or transient ischemic attack (TIA; doubled)–vascular disease, age 65 to 74 years, sex category (female; CHA2DS2-VASc) scores outperform other scoring systems in Asian populations and that the hypertension, abnormal renal/liver function (1 point each), stroke, bleeding history or predisposition, labile international normalized ratio (INR), elderly (>65 years), drugs/alcohol concomitantly (1 point each; HAS-BLED) score, a simple clinical score that predicts bleeding risk in patients with AF, particularly among Asians, performs better than other bleeding scores. A high HAS-BLED score should not be used to rule out OAC treatment but should instead prompt clinicians to address correctable risk factors. Therefore, the current review attempted to analyze available data from patients with nonvalvular AF who underwent stenting for ACS or CAD and elaborate on the direct-acting oral anticoagulant (DOAC) and antiplatelet management among such patients. For majority of the patients, “triple therapy” comprising OAC, aspirin, and clopidogrel should be considered for 1 to 6 months following ACS. However, the optimal duration for “triple therapy” would depend on the patient's ischemic and bleeding risks, with DOACs being obviously safer than vitamin-K antagonists.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A Pardo Sanz ◽  
L M Rincon ◽  
P Guedes Ramallo ◽  
L Belarte ◽  
G De Lara ◽  
...  

Abstract Aims Balance between embolic and bleeding risk is challenging in patients with cancer. There is a lack of specific recommendations for the use of antithrombotic therapy in oncologic patients with atrial fibrillation (AF). We compared the embolic and bleeding risk, the preventive management and the incidence of events between patients with and without cancer. We further evaluated the effectiveness and safety of direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) within patients with cancer. Methods The AMBER-AF registry is an observational multicentre study that analysed patients with non-valvular AF treated in Oncology and Cardiology Departments in Spain. 1237 female patients with AF were enrolled: 637 with breast cancer and 599 without cancer. Mean follow-up was 3.1 years. Results Both groups were similar in age, CHA2DS2-VASc and HASB-LED scores. Lack of guidelines recommended therapies was more frequent among patients with cancer. Compared with patients without cancer, adjusted rates of stroke (hazard ratio [95% confidence interval]) in cancer patients were higher (1.56 [1.04–2.35]), whereas bleeding rates remained similar (1.25 [0.95–1.64]). Within the group of patients with cancer, the use of DOACs vs VKAs did not entail differences in the adjusted rates of stroke (0.91 [0.42–1.99]) or severe bleedings (1.53 [0.93–2.53]). Follow-up events Conclusions Antithrombotic management of AF frequently differs in patients with breast cancer. While breast cancer is associated with a higher risk of incident stroke, bleeding events remained similar. Patients with cancer treated with DOACs experienced similar rates of stroke and bleeding as those with VKAs.


Author(s):  
Enrique Rodilla ◽  
Maria Isabel Orts-Martinez ◽  
Miguel Angel Sanz-Caballer ◽  
María Teresa Gimeno-Brosel ◽  
Maria Jesús Arilla-Morel ◽  
...  

The aim is to evaluate a program for direct oral anticoagulants (DOACs) management in nonvalvular atrial fibrillation (NVAF) patients, according to patient profiles, appropriateness of dosing, patterns of crossover, effectiveness and safety. This is an observational and longitudinal retrospective study in a cohort of patients attended in daily clinical practice in a single regional hospital in Spain with a systematic follow-up plan for up to 3 years for patients initiating dabigatran, rivaroxaban or apixaban between JAN/2012-DEC/2016. We analyzed 490 episodes of treatment (apixaban 2.5 mg: 9.4%, apixaban 5 mg: 21.4%, dabigatran 75 mg: 0.6%, dabigatran 110 mg: 12,4%, dabigatran 150 mg: 19.8%, rivaroxaban 15 mg: 17.8% and rivaroxaban 20 mg: 18.6%) in 445 patients. 13.6% of patients on dabigatran, 9.7% on rivaroxaban, and 3.9% on apixaban, switched to other DOACs or changed dosing. Apixaban was the most frequent DOAC switched to. The most frequent reasons for switching were toxicity (23.8%), bleeding (21.4%) and renal deterioration (16.7%). Inappropriateness of dose was found in 23.8% of episodes. Patients taking apixaban 2.5 mg were older, had higher CHA2DS2VASc score and lower creatinine clearance. Patients taking dabigatran 150 mg and rivaroxaban 20 mg were younger, had lower CHA2DS2VASc and higher creatinine clearance. Rates of stroke/transient ischemic attack (TIA) were 1.64/0.54 events/100 patients-years, while rates of major, clinically relevant non-major (CRNM) bleeding and intracranial bleeding where 2.4, 5, and 0.5 events/100 patients-years. Gastrointestinal and genitourinary bleeding were the most common type of bleeding events (BE). On multivariable analysis, prior stroke (RR: 4.2; CI: 1.5-11.8; p=0.006) and age (RR: 1.2; CI: 1.1-1.4; p=0.006) were independent predictors of stroke/TIA. Concurrent platelet inhibitors (RR: 7.1; CI: 2.3-21.8; p=0.001), male gender (RR: 2.1; CI: 1.2-3.7; p=0.0012) and age (RR: 1.1; CI: 1.02-1.13; p=0.005) were independent predictors of BE. This study complements the scant data available on the use of DOACs in NVAF patients in Spain, confirming a good safety and effectiveness profile


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18264-e18264 ◽  
Author(s):  
Ali McBride ◽  
Chinmayee Katragadda ◽  
Ivo Abraham

e18264 Background: The DOACs apixaban, edoxaban, rivaroxaban, dabigatran offer advantageous alternatives for venous thromboembolism (VTE) treatment in cancer patients, however, there lacks a prospective assessment in this population. We conducted a meta-analysis of RCTs comparing these DOACs to controls to evaluate the safety and efficacy of these new agents for patients with active cancer. Methods: We systematically searched PUBMED, EMBASE, Cochrane Reviews, CINAHL and Clinicaltrials.gov. Two authors (CK, IA) screened and reviewed abstracts and full text, with disagreements resolved by third author (AB). Data extracted included major bleeding and clinically relevant nonmajor bleeding for safety; recurrent VTE and VTE death for efficacy. Analyses included Mantel-Haenszel random effects risk ratios (RR); I2 for heterogeneity; and meta-regression by publication year. Results: Of 2307 records reviewed, 8 RCTs were retained. Pooled analysis yielded safety RR 0.82 (95%CI = 0.56-1.21, I2 = 44% ) and efficacy RR 0.94 (95%CI = 0.68-1.31; I2 = 0%). Meta-regression revealed no publication year bias. Conclusions: Current guidelines have not supported the use of DOACs in clinical cancer practice due to the paucity of data in this setting. Our results indicate no differential efficacy and no increased bleeding risk for DOACs in cancer patients. Additional prospective research is required to determine long term effects in subgroups of cancer patientss at higher risk for VTE or bleeding events. [Table: see text]


2017 ◽  
Vol 70 (10) ◽  
pp. 878-880
Author(s):  
César Caro Martínez ◽  
José Manuel Andreu Cayuelas ◽  
Pedro José Flores Blanco ◽  
Mariano Valdés ◽  
José Luis Bailén Lorenzo ◽  
...  

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